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Recall Observatory FDA recall evidence

Drug product

Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.

D-0180-2023

December 19, 2022

Class I

Product summary

Firm
Spectrum Laboratory Products, Inc.
Event
Event 91381
Status
Terminated
Classification
Class I
Quantity
7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G
Official record key
drug-enforcement:D-0180-2023

Official wording

Reason: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Code information: Lot # (a) (b) (c) (d) lot 2KL0353, EXP 30-Sep-2023; 2KF0151, EXP 31-Mar-2023

Distribution pattern: Nationwide in the USA, Puerto Rico and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Field note

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